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ProQuad Dose Selection Study (V221-011)(COMPLETED)

NCT00986232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1551

Last updated 2015-04-10

Study results available
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Summary

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Conditions

Interventions

BIOLOGICAL

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

BIOLOGICAL

Comparator: M-M-R II

A single 0.5 mL subcutaneous injection at Day 0

BIOLOGICAL

Comparator: PUVV

A single 0.5 mL subcutaneous injection at Day 0

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-04-30
Primary Completion
2000-04-30
Completion
2000-09-30

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986232 on ClinicalTrials.gov